Otezla Approved by the FDA for Plaque Psoriasis

The US Food and Drug Administration (FDA) approved apremilast, also known as Otezla and Celgene, for treating adults with moderate to severe plaque psoriasis. Earlier this year, this same drug was approved by the FDA for the treatment of psoriatic arthritis.

Otezla is an oral selective inhibitor of phosphodiesterase 4 (PDE4), and the first in this class approved specifically to treat plaque psoriasis. According to the news release, Otezala is intended for patients for whom phototherapy or systemic therapies are deemed appropriate.

In two multicenter, randomized, double-blind, and placebo-controlled studies, researchers tested apremilast. Involved in these studies were comprised of approximately 1,250 patients who had confirmed cases of moderate to severe plaque psoriasis.

These individuals were randomized 2 to 1 to be administered apremilast 30 milligrams two times a day or a placebo for the first 16 weeks of the study, followed by a maintenance phase anywhere from 16 to 32 weeks. During the maintenance period, placebo patients were instead given apremilast, 30 milligrams two times a day. From weeks 32 to 52, the study included a randomized withdrawal phase, based on both PASI-75 and initial Otezla randomization response.

By using Otezla to treat the participants in these studies, it was demonstrated that this drug had the ability to significantly and clinically provide meaningful improvement in plaque psoriasis. According to researchers, this determination came about by measuring PASI scores at week 16.

Scott Smith, president of Inflammation & Immunology at Celgene stated that Otezla provides a valuable and viable treatment option for a broad spectrum of plaque psoriasis patients. This includes patients who have received very little to no treatment, as well as those who have been on multiple treatment plans, both conventional systemic and biologic agents.